BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P030049 · Supplement: S004 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
    PMA Number
    P030049
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 9, 2009
    Date Received
    March 9, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICES ADVIA CENTAUR HBSAG AND ADVIA HBSAG CONFIRMATORY ASSAY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBSAG READYPACKREAGENTS. ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY AND ADVIA CENTAUR HBSAGQUALITY CONTROL MATERIAL ARE INDICATED FOR:ADVIA CENTAUR HBSAG READYPACK REAGENTSTHE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTION.THIS PRODUCT IS NOT FOR USE FOR TESTING OR SCREENING POOLED SAMPLES CONTAINING SPECIMENS FROM MORE THAN ONE INDIVIDUAL, OR OTHERWISE IN BLOOD OR PLASMA SCREENING.ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY:THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAYFOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA. LITHIUM OR SODIUM HEPARIN) USING THEADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIACENTAUR ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL:FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS WHEN USING SERUM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)